Application 090941
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 150MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090941-001 | BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2010-05-03 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2010-05-03 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2010-05-03 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A090941-001 | BUPROPION HYDROCHLORIDE | 150MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-03 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A090941-001 | AB2 | 1 | 74a2ff9319b5… |
| 2019-09-15 20:21 UTC | 2019-09 | A090941-001 | AB2 | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090941-001 | AB2 | 1 | ea99ee380514… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Chartwell RX, LLC | 620fab1e-aafb-444d-ab81-63281cd139c5 | 2024-10-14 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | ec8c699f-a8de-4e5a-a223-8de3f5dfe20d | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 7c46d95a-26f6-4364-8197-9e564e3405f2 | 2024-08-29 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | aeb506f8-97c2-409a-aac9-5a73c840e8f3 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| bupropion | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 7ded4fa6-e637-4d59-a1b1-286854d4fe3a | 2024-08-09 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 500fc18d-93b4-47d5-a3f7-3f68822d83e8 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 634bc654-be95-4fea-b308-eed53269a112 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | aef84c3a-68e2-e9d9-e053-2995a90a4ab8 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 0574b84d-075f-410f-a8eb-86901e307ea2 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Proficient Rx LP | 13560bf8-eb25-44f0-968e-db70d51219af | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | Epic Pharma LLC | 9fb44e96-6160-4a4a-90cb-91764c0dcd89 | 2024-06-21 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride XL | BUPROPION HYDROCHLORIDE | Slate Run Pharmaceuticals, LLC | 06d4d890-11ed-4f31-8778-c73432e3ea69 | 2024-06-16 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Slate Run Pharmaceuticals, LLC | 7c4313fa-bb29-dd50-e053-2991aa0a3005 | 2024-06-16 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 87dac2ee-732c-465b-8ffe-e5aeba421425 | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 78ef709a-f835-4b03-92dd-16a4c82af0c1 | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | a18b5460-fcbb-42dd-8b87-197d11a08928 | 2024-05-16 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| BUPROPION HYDROCHLORIDE | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 77b78d35-40f5-4713-8468-aa09a6c2925d | 2024-05-16 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | e962fb9a-d9fb-49c5-a8b4-0b355b8f829b | 2024-05-09 | Boxed warning, Warnings, Adverse reactions | Bupropion Hydrochloride BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | Proficient Rx LP | b59d950c-341f-45f1-b5b2-d64ccc799580 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
| Bupropion Hydrochloride SR | BUPROPION HYDROCHLORIDE | A-S Medication Solutions | 339c7157-1c65-40d1-bbcc-c10348d908d3 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | BUPROPION HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-5521 | Bupropion Hydrochloride | Bupropion Hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |